Sole Source Award Notice: Clarivate Analytics

The FDA is seeking access to well curated clinical trial knowledge database and search/analytics capabilities to assist FDA in reviewing and making an informed data-driven decision about the adequacy of the submitted data to support Drug Development Tool qualification. Licensing access to a suite of biomarker-related contents and analytical tools will be used to support and speed up the evaluation and recommendations for biomarker DDT submissions.

A notice of intent is issued a sole source to Clarivate Analytics with authority of the FAR Part 12.603 (c)(2)(i), this is a combined synopsis/solicitation for commercial items prepared in accordance with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. and If there are no responses have received in response to the posting. Therefore, it was determined that no other sources are capable and willing to provide acquisition of web access to Cortellis Clinical Trials Intelligence tools with related analytical modules offered by Clarivate. to Center for Drug Evaluation and Research (CDER)/Office of New Drugs (OND)/Office of Drug Evaluation Science (ODES).

Estimated Value: $234,626.10 for a base year.

In accordance with FAR Part 13.106-1(b), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available. For the reasons stated above, Clarivate Analytics is the only source considered in this procurement.